Impact of Surgical Mask, FFP2 Mask and FFP3 Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy (FFP-O2)

Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy

The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.

In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.

Study Overview

• Status: Completed
• Conditions: Face Mask; Longterm Oxygen Therapy
• Intervention / Treatment: Diagnostic test: 6-MWT; Diagnostic test: Spiroergometry

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Donaustauf, Bavaria, Germany, 93093
      • Klinik Donaustauf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with known lung disease hospitalized at normal wards.

Description

Inclusion Criteria:

• Known lung disease and
• LTOT
• informed consent

Exclusion Criteria:

• Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)
• Acute exacerbation of lung disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with known lung disease and LTOT (long term oxygen therapy); Patients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT	Diagnostic test: 6-MWT; Measurement of saturation and blood gas parameters under 6-MWT with different masks.; Other Names: Six minutes walk test; Diagnostic test: Spiroergometry; Measurement of saturation and blood gas parameters under spiroergometry with different masks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in capillary oxygen partial pressure	At the end of 6-MWT or spiroergometry
Increase in capillary carbon dioxide partial pressure	At the end of 6-MWT or spiroergometry

Collaborators and Investigators

• Sponsor: University Hospital Regensburg

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 22-3165-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No